Job Responsibilities
- Leads microbiology strategy for new product development initiatives, including sterility testing, environmental monitoring, bioburden, and experimental applications for the Growth Direct® System.
- Oversees day-to-day operations of the R&D microbiology laboratory, including resource planning, workflow optimization, equipment management, and budget control.
- Directs experimental design, validation studies, and feasibility programs within GLP/GMP frameworks.
- Provides technical leadership for growth media formulation, scale-up, and manufacturing validation.
- Serves as a microbiology SME for cross-functional product development teams, supporting design requirements, design verification, risk assessments, and regulatory submissions.
- Manages laboratory personnel, including hiring, performance management, mentoring, and career development.
- Ensures compliance with safety protocols, quality systems, and laboratory best practices.
- Oversees demo laboratory operations and customer application projects, supporting commercial growth and key account strategies.
- Partners with Quality and Manufacturing teams to align best practices and ensure scalable, compliant solutions.
- Reviews and approves complex technical reports, validation protocols, and study results.
- Leads technical investigations, root cause analyses, and risk-based decision-making related to customer support activities.
- Supports global customer engagements, technical presentations, and strategic account initiatives.
- Drives continuous improvement initiatives focused on efficiency, cost optimization, and scientific advancement.
- Manages laboratory inventory, capital planning, and instrument asset utilization.
- Completes special strategic projects including competitive analysis, statistical studies, and product feasibility assessments.
Education
- Bachelor’s degree in microbiology or related life science discipline required. Master’s degree preferred.
Work Experience
- 10+ years of progressive experience in pharmaceutical, biotech, CRO, CDMO, or regulated laboratory environments, including leadership experience in GLP/GMP settings.
Technical Experience
- Sterility testing, bioburden, and environmental monitoring
- Rapid microbiological methods
- Growth media formulation and validation
- Method validation and regulatory compliance
- Product development lifecycle in regulated environments
Leadership and Business Competencies
- Portfolio prioritization and cross-functional program leadership
- Budget management and capital planning
- Talent development and performance management
- Strategic thinking aligned to commercial objectives
- Strong analytical and risk-based decision-making skills
Skills Required
- Bachelor's degree in microbiology or related life science discipline
- Master's degree
- 10+ years of experience in pharmaceutical, biotech, or regulated laboratory environments
- Leadership experience in GLP/GMP settings
What We Do
Rapid Micro Biosystems is an innovative life sciences technology company providing mission-critical automation solutions to facilitate the efficient manufacturing and fast, safe release of healthcare products such as biologics, vaccines, cell and gene therapies, and sterile injectables. We are the trusted partner in quality control microbiology automation, enabling our customers to improve and save lives. This vision has been realized with the development of the Growth Direct® System. Our Growth Direct® platform automates and modernizes the antiquated, manual quality control microbiology testing workflows used in the largest and most complex pharmaceutical manufacturing operations across the globe. The Growth Direct® platform brings the quality control lab to the manufacturing floor, unlocking the power of in-line/at-the-line QC automation to deliver faster results, greater accuracy, increased operational efficiency, better compliance with data integrity regulations, and quicker decision making that customers rely on to ensure safe and consistent supply of important healthcare products. Our company values guide us in our vision: Customer Driven – We are committed to providing our customers with the highest quality products and services Respect – We welcome and embrace our differences to create a trusting environment Grit – We are determined to turn challenges into successes. One RMB – We operate as one team, committed to our shared purpose. The company is headquartered and has U.S. manufacturing in Lowell, Massachusetts, and global locations in Switzerland, Germany, and the Netherlands
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